Kornimate/medical-research-clean huggingface dataset:
primary chemoradiation vs. neoadjuvant chemotherapy followed by surgery as treatment strategy for lavc

Conditions: Locally Advanced Vulvar Carcinoma; Squamous Cell Carcinoma of the Vulva

Summary: a phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (nact; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with lavc, registered from eight national medical centres.


Eligibility criteria:
inclusion criteria: * woman ≥ 18 years * signed and written informed consent. * histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer figo stage ib - iva, t1b or higher, any n, m0. * local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of extensive surgery (meaning surgery damaging pelvic organs or exenterative surgery). this can imply; * t1b or larger tumour with (irresectable) groin metastases * t1b or larger tumour with a close relationship to and/or involvement of the urethra or anal sphincter * world health organization performance status of 0-2 * adequate haematological function defined by platelet count \>100x10e9/l, absolute leukocyte \>3x10e9/l or neutrophil count (anc) \>1.5x10e9/l, and hemoglobin \>6.0 mmol/l * adequate hepatic function defined by a total bilirubin level ≤1.5x the upper limit of normal (uln) range and asat and alat levels ≤2.5x uln for all subjects * adequate renal function defined by an estimated creatinine clearance ≥50ml/min according to the cockroft-gault formula (or local institutional standard method) * beta hcg level of 14 miu/ml or below for women of childbearing potential * highly effective contraception for patients if the risk of conception exists exclusion criteria: * patients with highly suspicious or positive metastases to the pelvic lymph nodes \* patients eligible for radical local excision without involvement of other organs * any psychiatric condition that would prohibit the understanding or rendering of informed consent * prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol * existing neuropathy which will hinder the intake of chemotherapy
salvage prostatectomy after radiotherapy

Conditions: Prostate Cancer

Summary: the purpose of this study is to compare the location of the cancer found in the prostate gland after it is removed to the location that was predicted on the mri scan during biopsy. in this way, we can better determine if the magnetic resonance imaging (mri) was accurate, and if the mri could be safely used to guide other types of treatments such as brachytherapy. we also plan to carefully measure how frequently surgery is able to completely remove the cancer, as well as the side effects and effectiveness of surgery after radiotherapy. the study will be coordinated and closely integrated with a separate concurrent study of mri-guided prostate biopsy, which will be performed prior to accrual to this trial (uhn 05-0641-c).

two hundred and nineteen thousand new cases of prostate cancer have been projected in the unites states for 2007, with external beam radiotherapy (ebrt) constituting the mainstay of local therapy for an increasing proportion of newly diagnosed patients. despite improvements in the delivery and reduction in associated toxicity of external beam radiotherapy, local persistence or recurrence of disease remains prevalent in 25-51% of patients. local disease after ebrt is a risk factor for subsequent metastatic progression and prostate cancer-specific mortality, and is a cause of morbidity including hematuria, obstructive uropathy, and chronic pain. given its prevalence, and the lack of satisfactory local salvage treatments, fear of prostate cancer recurrence has been shown to impose a substantial burden of suffering in patients. stereotactic needle placement under mri-guidance enables two critical steps in tumor-targeted brachytherapy: 1) directly guiding brachytherapy catheters to sites of tumor recurrence, and 2) permitting treatment planning and delivery to be based on 3d mri images. mri-based hdr brachytherapy will precisely identify the location of brachytherapy catheters relative to the target volumes and adjacent normal structures at risk of radiation injury, obviating the need for invasive saturation (24-100) mapping biopsies. this study will build the evidence supporting the concept of tumor-targeted salvage hdr brachytherapy, by providing further histopathological validation of the method.

Eligibility criteria:
inclusion criteria: * prior enrollment of uhn 05-0641-c * histological evidence of cancer on mri-guided prostate biopsy * psa doubling time \> 6 months * ecog 0 or 1 * all patients must give written informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed exclusion criteria: * contraindications to salvage prostatectomy * previous rectal surgery for ibd or cancer such that an ileo-anal anastomosis is present. * radiological evidence of regional or distant metastases

Keywords: prostate cancer prostatectomy radiotherapy prostatectomy after radiotherapy
investigation of the effects of proprioceptive neuromuscular facilitation exercises in patients with myasthenia gravis

Conditions: Myasthenia Gravis

Summary: the goal of this clinical trial is to investigate of the effects of proprioceptive neuromuscular facilitation exercises on fatigue, muscle strength and functional parameters in patient with myasthenia gravis. the main questions it aims to answer are: * do proprioceptive neuromuscular facilitation exercises reduce fatigue in patients with myasthenia gravis? * do proprioceptive neuromuscular facilitation exercises increase muscle strength in patients with myasthenia gravis? * do proprioceptive neuromuscular facilitation exercises improve functional parameters in patients with myasthenia gravis? * how well can patients with myasthenia gravis tolerate proprioceptive neuromuscular facilitation exercises? participants will be divided into 2 groups as control group and exercise group with block randomization method. in this single-blind randomized controlled study, the participants in the control group will be placed on a waiting list without any intervention during the 6-week study period and at the end of the study, the interventions applied to the exercise group will be applied exactly the same. proprioceptive neuromuscular facilitation exercises will be applied to the exercise group 3 days a week, 1 hour a day for 6 weeks. individuals will be evaluated at the beginning and at the end of the study. researchers will compare exercise and control group to see if there are effects of proprioceptive neuromuscular exercises patients with myasthenia gravis.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * being between the ages of 18-65 * it must be confirmed by the neurologist that the patient has been diagnosed with adult onset and achr+ generalized myasthenia gravis and has been in a stable condition for the last 6 months. * being in class ii or iii according to the american myasthenia gravis foundation clinical classification exclusion criteria: * having a cognitive problem or having a mini mental test score below 24 * change in the type and dose of medical treatment within the last 6 months * having another cardiorespiratory, metabolic, systemic, rheumatological, orthopaedic and neurological disease (unstable and at a level that prevents participation in the exercise programme) in addition to myasthenia gravis * having a body mass index below 17 kg/m2 and above 30 kg/m2 * having participated in any physiotherapy program any intervention study for the last 6 months * having undergone pregnancy, birth or surgical operation in the last 6 months.
mutations, hormone therapy (hrt) and venous thromboembolism

Conditions: Cardiovascular Diseases; Venous Thromboembolism; Postmenopause

Summary: to assess the interaction between hormone replacement therapy and the prothrombotic mutations, factor v leiden and the recently described prothrombin mutation (20210a) on the incidence of venous thromboembolism (vte) in a population-based case-control study conducted at group health cooperative of puget sound (ghc).

background: epidemiologic studies have identified factor v leiden as the most common cause of heritable thrombophilia, a prothrombotic mutation associated with a 5 to 7-fold increase in the risk of venous thromboembolism (vte). in pre-menopausal women, the use of oral contraceptives is associated with a 4-fold increase in vte risk, and the joint effects of oral contraceptive use and factor v leiden carriership increase the vte risk of by a factor of 35. recently, the results of several observational studies and randomized clinical trials suggest that in post-menopausal women, the use of hormone replacement therapy is associated with a 3-fold increase in vte risk. whether post-menopausal women with prothrombotic mutations experience a similar 20-fold increase in risk when they take post-menopausal hormones remains unknown. design narrative: in this case-control study, post-menopausal women with a first episode of objectively confirmed venous thromboembolism, and population-based controls were identified and recruited from the ghc enrollment files. controls were frequency matched to the cases on age and calendar-year. data collection included a review of ambulatory medical record and a telephone interview. the ghc computerized pharmacy database was used to assess exposure to hormone replacement therapy. a venous blood specimen was obtained from consenting subjects, processed into aliquots of white cells, plasma, and red cells, and stored at 70 degrees c prior to laboratory analysis. dna was extracted from white cells, and molecular genotyping assays were conducted to assess carriership of prothrombotic mutations.

Eligibility criteria:
no eligibility criteria
sleep tms for depression

Conditions: Major Depression; Sleep

Summary: the goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (tms) for enhancing plasticity in depression treatment.


Eligibility criteria:
inclusion criteria: * current major depressive disorder (mdd) diagnosis * failed \>= 1 antidepressant medication * moderate-to-severe depression exclusion criteria: * intellectual disability * significant head injury/neurological disorder * pregnancy or postpartum * tms/mri contraindications * active substance use/suicidal ideation

Keywords: sleep tms eeg
ahsct with fludarabine and cyclophosphamide based conditioning regimes in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: one of the possible options for the treatment of ms at present is a high-dose immunosuppressive therapy followed by autologous hematopoietic stem cell transplantation (hist-ahsct), which is a highly effective treatment for patients with relapsing-remitting ms. this method of ms treatment was introduced in 1997. significant complications and mortality associated with hist-athsc is an obstacle to broad use of this method. the risk is even greater in patients with advanced disease, long duration of previous treatment and aggressive forms of ms. despite toxicity certain progressive cases of ms are still an indication for hist-autohsct. most commonly used conditioning regimens for multiple sclerosis include high-dose cyclophosphamide. one of the options to reduce cyclophosphamide-related toxicity and dose is addition of fludarabine. fludarabine is a cytostatic drug, an antimetabolite from the group of purine antagonists. it has a pronounced immunosuppressive activity and no overlapping toxicity with cyclophosphamide. the study will evaluate the safety and efficacy of this combination.


Eligibility criteria:
inclusion criteria: * age 18-65; * 1.0-6.5 points on the edss scale (for ms); * length of illness - any; * disease progression during the last 6 months while taking drugs of 1st and 2nd lines; * an established and confirmed diagnosis of an autoimmune disease in the previous stages of treatment; * ineffectiveness, inaccessibility or intolerance of disease-modifying therapies; * relapse after ahsct. * absence of severe concomitant somatic pathology; * left ventricular injection fraction \> 50%; * karnofsky performance score (kps) \> 30%; * the ability to take oral medications; * life expectancy is more than 1 month; * signed informed consent of the patient or legal representatives. exclusion criteria: * moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50% * moderate or severe decrease in pulmonary function, fev1 \<70% or dlco\<70% of predicted * respiratory distress \>grade i * severe organ dysfunction: ast or alt \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits * creatinine clearance \< 60 ml/min * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * karnofsky performans status \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign informed consent

Keywords: autoimmune diseases ahsct fludarabine
efficacy and safety of cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (hsil)

Conditions: Cervical Intraepithelial Neoplasia Grade 2/3

Summary: a double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (hsil).

to evaluate the efficacy and safety of cevira® compared to placebo in treatment of patients with cervical histologic hsil.a total of 384 subjects will be enrolled globally, among which, 300 subjects of them will be enrolled in china.

Eligibility criteria:
inclusion criteria: 1. biopsy-confirmed hsil histology determined by a panel of 3 pathologists from a central laboratory in each region (china, us, and europe); 2. adequate colposcopy including: 1. visualization of entire cervical transformation zone including the squamocolumnar junction 2. visualization of entire lesion margin 3. colposcopically visible lesion after biopsy, before treatment (note: to ensure a colposcopically visible lesion after biopsy, the lesion should cover approximately 15% of the uterine cervix before biopsy) 4. average sized uterine cervix suitable for application of the cevira® device 5. use of adequate birth control until completion of the 6 month assessment visit 6. age 18 or older (note: patients aged 18-20 should not be actively recruited) 7. signed written informed consent exclusion criteria: 1. biopsy-confirmed hsil (cin3) histology with a total lesion area covering more than half of the uterine cervix area 2. invasive cervical cancer 3. adenocarcinoma in situ, or other glandular intraepithelial lesions 4. lesion(s) extending to the cervical canal (as clinically indicated and whether to perform endocervical curettage \[ecc\] test at the discretion of the investigators) 5. lesion(s) extending to the vaginal vault 6. current severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infection as per colposcopy and clinical examination 7. vaginal bleeding at time of treatment at the discretion of the investigator 8. pregnancy 9. nursing 10. childbirth or miscarriage within six weeks of enrolment 11. patients who previously received surgical treatment, have incomplete cervical structure and have recurrent hsil; or patients who received other treatment after the confirmed diagnosis of hsil 12. history of toxic shock syndrome 13. known or suspected porphyria 14. known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid) 15. known allergy to silicone 16. use of heart pacemaker 17. participation in other therapeutic clinical trials using investigational agents either concurrently or within the last 30 days 18. patients that in the investigator's opinion are not suitable for participation 19. patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
efficacy of neonatal release of ankyloglossia

Conditions: Ankyloglossia

Summary: the purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.

the primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.

Eligibility criteria:
inclusion criteria: * significant ankyloglossia as judged by hazelbaker scale (hatlff) * report of maternal nipple pain with feeding * report of difficulty with infant breast feeding exclusion criteria: * significant craniofacial defects * age \>14 days at enrollment * any maternal contraindication to breastfeeding * neurologic defects that would impair breast feeding

Keywords: ankyloglossia tongue tie frenotomy frenulectomy breast feeding hatlff ibfat
intraoperative hygiene measures and surgical site infections

Conditions: Surgery; Surgical Site Infection; Hygiene; Discipline; Colorectal Surgery

Summary: surgical site infections are associated with high morbidity and cost hypothesis: extended intraoperative hygiene measures decrease surgical site infections in general surgery compared to standard hygiene measures.

intraoperatively two types of hygiene measures were performed randomly: standard and extensive. standard hygiene measures included empiric accepted measures (e.g. gloves, masks, disinfection). extensive hygiene measures included among others: double gloving, astro caps, extensive disinfection, extensive intraoperative rinsing. in addition, intraoperative adherence to the rules of asepsis were registered by an independent observer. patients were followed for 30 days.

Eligibility criteria:
inclusion criteria: * patient undergoing surgical operation in one of two assigned operative theaters. only initial operations are studied exclusion criteria: * previous inclusion into study
comparing intensive and standard training for human insulin inhalation powder (hiip)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare intensive and standard training for human insulin inhalation powder in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 months * age 18 or older. * taking at least 1 oral antihyperglycemic medication. * have an hba1c between 7.5 and 12. * be a nonsmoker exclusion criteria: * body mass index (bmi) greater than 40. * have frequent episodes of severe hypoglycemia. * have advanced autonomic neuropathy. * have history of asthma. * have chronic obstructive pulmonary disease (copd).
68ga-rm2 for pet/ct of gastrin releasing peptide receptor (grpr) expression in prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to see if a new diagnostic research agent named 68ga-rm2 can show prostate cancer on a pet/ct scan. 68ga-rm2 stands for galium-68 labeled dota-4-amino-1-carboxymethylpiperidine-d-phe-gln-trp-ala-val-gly-his-sta-leu-nh2. this study is being done because there are unmet medical needs to improve the current ways of detecting prostate cancers before surgery.


Eligibility criteria:
inclusion criteria: * age ≥18 years * biopsy proven adenocarcinoma of the prostate * patients with low-risk, intermediate-risk and high-risk tumors according to nccn guidelines (2.2014) will be included * planned radical prostatectomy at mskcc * multiparametric mri of the pelvis (performed or planned) as routine care exclusion criteria: * patients meeting any of the following exclusion criteria will not be eligible for study entry: * hematologic * platelets \<75k/mcl * anc \<1.0 k/mcl * hepatic laboratory values * bilirubin \>2.0 x uln (institutional upper limits of normal) * ast/alt \>2.5 x uln * renal laboratory values o creatinine \> 2.0 x uln * claustrophobia interfering with mri and pet/ct imaging * prior pelvic radiation * prior androgen deprivation therapy * patients deemed not surgical candidates due to prohibitive co-morbidities

Keywords: 68ga-rm2 pet/ct scan gastrin releasing peptide receptor (grpr) 14-146
natural orifice translumenal endoscopic surgery (notes): laparoscopic assisted transvaginal ventral hernia repair

Conditions: Umbilical Hernia; Ventral Hernia

Summary: this is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (notes) for ventral hernia repair, that will include questionnaires administered throughout the study. subjects enrolled will be those intending to have a transvaginal notes ventral hernia repair. data will be collected and reviewed through 12 months post-op.


Eligibility criteria:
inclusion: 1. umbilical or incisional hernia greater than 2 cm in size 2. female, age 18-75 3. mentally competent to give informed consent 4. scheduled to undergo a transvaginal notes ventral hernia repair exclusion: 1. pregnant women 2. patients with defects measuring greater than 10 cm in size 3. patients with complex hernias requiring fascial mobilization for closure 4. morbidly obese patients (bmi \>45)

Keywords: umbilical hernia ventral hernia